Kornimate/medical-research-clean huggingface dataset:
blinatumomab plus reduced-dose chemotherapy in treating b-all

Conditions: Precursor B-Cell Acute Lymphoblastic Leukemia

Summary: precursor b cell acute lymphoblastic leukemia (b-all) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation. in the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of b-all patients has significantly improved. in this study，we propose a treatment approach that combines blinatumomab and reduced-dose chemotherapy in b-all adults. our study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.

this is a prospective, single-arm, phase ii and open-label study. a total of 20 ph-negative b-all participants will be enrolled. the primary endpoint is mrd-negative cr rate. the induction therapy is a combination of blinatumomab(blina), vindesine(vds), cyclophosphamide(ctx) and dexamethasone(dxm). the second cycle would be the combination of blina and venetoclax(ven). as for consolidation therapy, we suggest the bone marrow transplantation. the purpose of this study is to explore the safety and efficacy of the treatment regimen in the treatment of newly diagnosed young ph-negative b-all patients.

Eligibility criteria:
inclusion criteria: * 1. before enrollment, patients must be diagnosed with de novo precursor b-cell acute lymphoblastic leukemia and be negative for philadelphia chromosome. the diagnostic criteria refer to the 2022 who classification; 2. age≥15 years， ≤59 years; 3. eastern cooperative oncology group (ecog) performance status score of 0-2; 4. expected survival time ≥ 2 months; 5. no organ dysfunction that would restrict the use of this protocol during the screening period; 6. understand the study and sign the informed consent form. 7. men, women of childbearing age (only postmenopausal women who have been menopausal for at least 12 months can be considered infertile), and their partners voluntarily take effective contraceptive measures deemed effective by the investigator during the treatment period and for at least 12 months after the last dose of the study drug. exclusion criteria: * 1. patients with known central nervous system (cns) involvement of all; 2. diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, copd, bronchiectasis, etc.); 3. cardiac ultrasound lvef \ 1.5 uln (upper limit of normal); alt or ast \> 2.5 uln; serum creatinine \> 1.5 uln; 6. known hiv infection; 7. conditions affecting the use of the study drug as assessed by the investigator; 8. unable to understand or comply with the study protocol.

Keywords: acute lymphoblastic leukemia chemotherapy immunotherapy
evaluating a community-based exercise intervention with adults living with hiv: an interrupted time series study

Conditions: HIV

Summary: the primary aim of this research is to evaluate a community-based exercise (cbe) intervention for adults living with hiv within the community with the goal of reducing disability and enhancing health (cardiopulmonary, strength, weight and body composition, and neurocognitive outcomes) and contextual factor outcomes (social support, stigma, mastery, coping) for adults living with hiv.

investigators will use the re-aim framework to evaluate the community-based exercise (cbe) intervention. the re-aim framework includes criteria to evaluate the impact and translation of an intervention at both individual and organizational-levels in order to promote uptake, transferability and ultimately enhance the public health impact of health promotion interventions. specific study objectives are: 1) to determine the extent (proportion of sessions attended, frequency, intensity, time, type) to which adults with hiv participate in a cbe intervention; 2) to assess the effect of a cbe intervention on disability and health outcomes and intrinsic and extrinsic factor outcomes for people living with hiv; 3) to assess engagement in cbe for adults with hiv over time (adherence, level of physical activity); and 4) to evaluate the process (strengths and challenges; feasibility; accessibility, long term sustainability) of implementing a cbe intervention within the community from the perspective of recreation providers (fitness instructors; managers) and people living with hiv. investigators will conduct a prospective longitudinal study using mixed methods to evaluate a cbe intervention in the community with people living with hiv. they will use an interrupted time series (its) design in combination with qualitative interviews to assess outcomes at baseline (pre-testing phase), during (intervention phase) and after the cbe intervention (post-testing phase) to evaluate the short- and long-term effect of cbe.

Eligibility criteria:
inclusion criteria: * adults (18 years and older) living with hiv in toronto who consider themselves medically stable and safe to engage in exercise and who are willing to participate in a 22 month study involving a 14 month cbe intervention at the ymca. exclusion criteria: * not applicable.

Keywords: hiv disability rehabilitation exercise
the comparative clinical study of gamisoyosan on anxiety of generalized anxiety disorder according to dosage form

Conditions: Generalized Anxiety Disorder

Summary: in this randomized, double blinded, parallel-controlled study, the investigators planned to give gamisoyosan extract, gamisoyosan extract powder or controlled medication on anxiety of generalized anxiety disorder according to dosage form.


Eligibility criteria:
inclusion criteria: * male or female aged 20-65 * (structured clinical interview for dsm-ⅳ axis ⅰ disorder, scid-ⅰ) subjects who meet structured clinical interview for dsm-ⅳ axis ⅰ disorder, scid-ⅰof generalized anxiety disorder exclusion criteria: * currrent or past history of delusions, halucination * past history of at least one manic episode, hypomanic episode, or mixed episode * current or past history of alcohol abuse or alcohol dependence history * taking substances(e.g. antianxiety drugs, antidepressant, antipsychotic drug, steroids, female hormonal drug, l-dopa, digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine) which might affect symptoms * medical conditions(e.g. myocardial infarction,brain tumor, multiple sclerosis, pancreatic disease, hyperthyroidism, hypothyroidism, addison disease, cushing disease, rheumarthritis, cancer, cva, epilepsy, anemia, pituitarium disease, vit b12 deficiency disease, pms) that might affect symptoms * current with hepatoma, hepatic cirrhosis, chronic renal failure, congestive heart failure * pregnancy, lactation, women not using medically accepted means of birth control * considered not apt to carry out clinical trial

Keywords: generalized anxiety disorder jingji-zhengchong gamisoyosan anxiety
patient navigator to reduce readmissions

Conditions: Chronic Obstructive Pulmonary Disease; Heart Failure; Sickle Cell Disease; Myocardial Infarction; Pneumonia

Summary: staying out of the hospital is valued by patients and their caregivers. their interests converge with those of hospitals now that high 30-day readmission rates for some conditions place hospitals at risk for financial penalties from the centers for medicare and medicaid services. this study focuses on developing and testing a program that combines a community health worker (lay patient advocate, acting as a "patient navigator") and a peer-led telephone support line to improve patient experience during hospital to home transition.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older on date of hospital admission 2. hospitalized at the university of illinois hospital, chicago 3. admission diagnosis, per treating physician, of pneumonia, copd, sickle cell disease, heart failure, or myocardial infarction 4. receive medical care on an inpatient medical service exclusion criteria: 1. unable to understand and speak english 2. unable/decline to give informed consent 3. previous participant in partner 4. planned transfer to another acute care facility 5. planned discharge to facility other than home (e.g. long term care facility) 6. currently on hospice or plans to discharge home to hospice 7. current plans to leave against medical advice

Keywords: patient navigators readmissions peer coaching
hyperlactatemia during and after tumorcraniotomy

Conditions: Hyperlactatemia; Brain Tumor; Surgery; Anesthesia

Summary: this study aims to investigate the association between hyperlactatemia and neurological disability, length-of-stay and mortality in patients who undergo tumorcraniotomy. the risk factors that induce lactat accumulation will also be explored.

hyperlactatemia is a frequent occurrence in brain tumor surgery. the existing studies, however, are all retrospective, reporting varying effects on clinical outcome. one study reported new neurological deficitis, some found an association with extended hospital stay, while others found no association with outcome. it is therefore important to conduct a prospective study of hyperlactatemia in this patientgroup. participants in this study will follow the standard treatment protocol for tumorcraniotomy, aside from 2-3 additional, perioperative blodgas analyses and 2 standardized measurements of neurological disability.

Eligibility criteria:
inclusion criteria: * age \>/= 18 years * must undergo elective tumor craniotomy * understand oral and written danish exclusion criteria: * adults with incapacity * stereotactic biopsy * lack of informed and signed consent to participate in study
circulating tumor dna alterations in non-small cell lung cancer patients treated with pembrolizumab

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to learn how to use blood tests to better predict how patients with non-small cell lung cancer, who are taking pembrolizumab for cancer treatment, will respond to treatment with pembrolizumab, and to understand how the immune system and cancer interact. tests will be performed on tumor tissue and blood samples, and imaging assessments will be reviewed in order to monitor how well each patient responds to treatment. this is an observational study, so participants will not receive cancer treatment, other than the treatment received as standard of care.

the primary and secondary endpoints of this study are to determine the kinetics of circulating tumor dna (ctdna) as defined by a set of patient-specific tumor mutations. the analysis will be undertaken using the signatera assay from natera. circulating tumor dna in plasma samples obtained over the course of pembrolizumab treatment will be assessed by high-intensity, next-generation genetic sequencing to identify genomic alterations in genes. the assay will target 16 defined patient specific mutations. data acquired will be analyzed to characterize the association between these genetic elements, clinical response, and durability of responses. there will be prospective and retrospective groups for the study. samples will be collected from patients in the prospective cohort who have been treated with pembrolizumab monotherapy at columbia university irving medical center under standard of care treatment. subjects in the retrospective cohort will provide genetic data.

Eligibility criteria:
inclusion criteria: 1. diagnosis of nsclc with a protein that acts as a kind of "brake" to keep the body's immune responses under control called programmed death ligand-1 (pd-l1) tumor proportion score (tps) ≥ 1% and no known alterations in driver genes epidermal growth factor receptor (egfr), anaplastic lymphoma kinase (alk), or receptor tyrosine kinase (ros1). 2. retrospective cohort: subjects must consent to provide genetic data from previous whole exome sequencing (wes) in the form of fastq/bam files (files that represent aligned genetic sequences) for creation of plasma ctdna panels. 3. prospective cohort: subjects must consent to provide available archived tumor and blood for wes (matched tumor and normal) for creation of plasma ctdna panels. the tumor sample must be from a site that was not previously irradiated or has progressed after radiation. 4. ability to understand and the willingness to sign a written informed consent document. 5. willing to comply with clinical trial instructions and requirements. 6. both men and women of all races and ethnic groups are eligible for this trial exclusion criteria: 1. age \<18 years 2. known history of autoimmune disease or other medical conditions that would preclude safe treatment with pembrolizumab.

Keywords: cancer immune system lung cancer pembrolizumab
phase i/ib trial of lsz102 single agent or lsz102 + lee011 or lsz102 + byl719 in er+ breast cancers

Conditions: Advanced or Metastatic ER+ Breast Cancer

Summary: to characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (pk), pharmacodynamics (pd) and anti-tumor activity of lsz102 as a single agent and in combination with either lee011 or byl719 in adult patients with locally advanced or metastatic er+ breast cancer who have progressed after endocrine therapy.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained prior to any procedures * histologically and/or cytologically confirmed diagnosis of er+/her2- breast cancer * advanced or metastatic breast cancer * must be able to swallow tablets and capsules exclusion criteria: * symptomatic cns metastases * patients whose laboratory values do not meet protocol criteria * clinically significant cardiac disease * impaired gastrointestinal function (gi) or gi disease that may significantly alter the absorption of oral medications other protocol defined inclusion/exclusion criteria may apply.

Keywords: lsz102 lee011 ribociclib kisqali byl719 alpelisib er+ breast cancer advanced er+ breast cancer metastatic er+ breast cancer serd serm fulvestrant tamoxifen aromatase inhibitor esr1 mtesr1 wtesr1 estrogen receptor endocrine therapy
effect of a bolus of clonidine systemically administered on the excitability of the spinal motoneurons of the lower extremity

Conditions: Intraoperative Neurophysiological Monitoring; Pain Management

Summary: the purpose of this study is to assess the effect of iv clonidine administration on lower limb spinal motoneuron excitability during standardized total intravenous anesthesia (propofol and remifentanil).

according to the literature data, intraoperative administration of clonidine reduces the need for morphine per and postoperative and thus reduces the side effects associated related to their administration. nevertheless, on the basis of current knowledge, clonidine may disrupt some electrophysiological measures required for the intraoperative monitoring of surgeries with a high risk of neurological complications. for such surgery, anaesthesiologists are led to inject clonidine after surgery, at a time when the electrophysiological measures are no longer needed, which limits the benefit in terms of intraoperative morphine savings. whith this study, investigators would like to investigate if an early administration of clonidine in patients aged 6 to 16 years undergoing ear surgery disturbs excitability of the spinal motor neuron. the choice of the study population is justified by the fact that the ear surgery does not require electrophysiological monitoring and it is carried out under conditions similar to that of anesthesia of scoliosis corrective surgery for which electrophysiological measurements are essential for the prevention of neurological complications. observations will allow investigators to determine therefore whether early administration of clonidine is possible at high risk of neurological complications surgeries for which electrophysiological monitoring is essential.

Eligibility criteria:
inclusion criteria: 1. patients aged 6 to 18 years at time of hospital admission 2. planned hospital admission for tympanoplasty 3. informed consent signed by both parents exclusion criteria: 1. known hypersensitivity to clonidine or to any component of the catapressan 2. patient treated with alpha2 agonists 3. surgical emergency 4. patient treated with antipsychotic drugs(butyrophenone, phenothiazine, tricyclic antidepressant) 5. abnormal heart rhythms 6. neuromuscular disease 7. renal impairment 8. patient treated with methylphenidate 9. pregnant or breastfeeding woman
effects of intensive chiropractic care to usual care for adults with spinal cord injuries.

Conditions: Spinal Cord Injuries

Summary: to determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in spinal cord injuries in adults.


Eligibility criteria:
inclusion criteria: * adults with both genders (male and female). * age above 20 years. * spinal cord injuries adults. exclusion criteria * spinal cord injury due to traumatic brain injury. * patients having cognitive impairments. * patients having associated neurological pathologies. * patients who are unable to follow the treatment plan.
the efficacy of a minimally invasive direct cochlear access via the hearo procedure

Conditions: Sensorineural Hearing Loss

Summary: to study the efficacy of a minimally invasive direct cochlear access via the hearo procedure.


Eligibility criteria:
inclusion criteria: adult cochlear implant candidates with suitable anatomy opting for a med-el cochlear implant. exclusion criteria: * age under 18 years * pregnancy * distance of the planned trajectory to the facial nerve is \< 0.4mm * distance of the planned trajectory to the chorda tympani is \< 0.3mm * vulnerability * invalid or withdrawn informed consent
efficacy of a mechanical gait repetitive training technique in hemiparetic stroke patients (avc)

Conditions: Hemiplegia; Stroke

Summary: modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. this study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement.

modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. the aim of the study is to test the efficacy of a body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gait-like movement compared to a conventional rehabilitation program in the acute phase. hemiparetic stroke patients will be randomly included in a 4 week rehabilitation program associating physiotherapy and gait trainer therapy or physiotherapy alone. the primary endpoint will be the walking speed (time needed to walk 10 m) at the end of the rehabilitation program. functional ambulatory category, walking endurance, time to self sufficient gait recovery, needing for mobility and self assistance, spasticity and economic evaluation of the two strategies will also be assessed.

Eligibility criteria:
inclusion criteria: * men or women aged 18 years or more * hemiplegia secondary to stroke * interval between stroke and study inclusion of 4 month or less * first supratentorial stroke or no motor sequelae in case of history of transient ischemic stroke * non ambulatory patient (functional ambulatory category stage 0 or 1) * being able to sit unsupported at the edge of the bed * no severe impairment of cognition or communication * written informed consent exclusion criteria: * orthopedic and/or rheumatological disease impairing mobility * other neurological associated disease * history of myocardial infarction or deep venous embolism or pulmonary embolism less than 3 months before study inclusion * chronic pulmonary disease * intolerance to stand up

Keywords: gait trainer hemiplegia rehabilitation stroke
the safety and effectiveness of steep pulse therapy system for the ablation of benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the goal of this clinical trial is to assess the efficacy of steep pulse ablation in treating benign prostatic hyperplasia (bph) and to evaluate its safety profile in treating bph. the main questions it aims to answer are: 1. whether steep pulse ablation can effectively manage bph symptoms and to investigate any potential safety concerns associated with its use in treating bph. 2. if steep pulse ablation can perform superior effect than tamsulosin hydrochloride in treating bph. participants will be asked to do: 1. participants will be given tamsulosin hydrochloride or undergo steep pulse ablation. 2. participants will be followed up after 1 month and 3 month after taking drug or undergo ablation for test and relative examinations.


Eligibility criteria:
inclusion criteria: 1. patients with bph diagnosed through digital rectal examination, b-mode ultrasound and urinary flow rate. 2. international prostate symptom score(ipss)\>=12. 3. maximum urinary flow rate between \>5ml/s and \<15ml/s with a minimum voided volume ≥ 150ml. 4. age ≥ 50 years old. 5. subjects are willing to participate and have signed the informed consent form. exclusion criteria: 1. patients with acute or severe urinary tract infections. 2. patients clinically diagnosed with prostate cancer. 3. patients with neurogenic bladder or bladder dysfunction due to other factors. 4. patients with urethral stricture. 5. patients who have undergone previous prostatectomy (turp), enucleation, or laser surgery. 6. patients with implanted pacemakers or metal replacements in the pelvis or hip joints. 7. patients who cannot tolerate general anesthesia or surgery due to severe systemic diseases, heart diseases, pulmonary insufficiency, failure of vital organs, or other reasons. 8. patients in the trial group who have taken medications that can affect bph symptoms within 3 months of postoperative follow-up. 9. patients who have participated in other drug trials or medical device clinical trials within 3 months prior to enrollment. 10. patients deemed unsuitable for participation in this clinical trial by the investigator.

Keywords: steep pulse ablation